Transcription of STRENGTH AND STABILITY TESTING FOR COMPOUNDED …
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STRENGTH AND STABILITY TESTING FOR COMPOUNDED …
1 STRENGTH AND STABILITY T ESTING FOR COMPOUNDED PREPARATIONSi USP Compounding Expert Committee:a Loyd V Allen Jr , PhD,b Gus S Bassani, PharmD,c Edmund J Elder Jr, PhD,d Alan F Parr, PharmDe a Correspondence should be addressed to: Rick Schnatz, PharmD, Manager Compounding and Healthcare Standards, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel. ; e-mail b International Journal of Pharmaceutical Compounding, Edmond, OK. c PCCA, Houston, TX. d University of Wisconsin, Madison, WI. e GlaxoSmithKline, Research Triangle Park, NC. ABSTRACT Tests for STRENGTH are designed to determine how much of an active ingredient is in a sample. STABILITY tests are used to determine an expiration date of a product or a beyond-use date of a preparation. Being able to understand the difference between STRENGTH TESTING versus STABILITY TESTING is the key to using the proper method to determine STRENGTH or STABILITY .
Jan 13, 2014 · The issue is that many “strength” tests do not separate the intact drug from the degradation products, and the degradation products show up under one peak in the chromatogram, thus giving the false information that the drug concentration has not changed, when it actually has. A stability-indicating assay, properly performed, will separate the
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